RecruitingNot Applicable

Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion

United States60 participantsStarted 2024-12-06

Plain-language summary

This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery. In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
✓. decreased disc height by \> 2 mm, but dependent upon the spinal level
✓. Grade II or more listhesis
✓. TLICS equal or greater than 5
✓. Unstable burst fracture

What they're measuring

Radiographic Fusion by CT Scan

Timeframe: Month 12

Trial details

NCT IDNCT04679844

SponsorKuros Biosurgery AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-02

Contact for this trial

Cesar Silva, MD

9702156793 cesar.silva@kurosbio.com

View on ClinicalTrials.gov More Degenerative Disc Disease trials